Having leapt the cardiovascular (CV)-risk hurdle set by the FDA for Contrave (naltrexone/bupropion) with early results from the Phase III trial known as the Light Study, Orexigen Therapeutics Inc. can start to resubmit its new drug application (NDA) for the obesity drug, which could be approved in the U.S. by next summer. Read More
Armo Biosciences Inc. began testing its pegylated recombinant human interleukin-10 (IL-10) compound, AM0010, in the first cohort of patients in a Phase I trial in patients with advanced solid tumors. Read More
Medivir AB pocketed a €10 million (US$13.5 million) milestone from partner Johnson & Johnson following the FDA approval of its hepatitis C virus (HCV) protease inhibitor (PI) simeprevir, which will be marketed as Olysio. Read More
LONDON – Pulmocide Ltd. has raised £17 million (US$27.5 million) in Series A funding to embark on the discovery of a new generation of inhaled treatments for serious viral and fungal infections of the respiratory tract. Read More
Endothelial cells, which line the blood vessels, have been increasingly recognized as playing important roles in the health and regeneration of the organs their blood vessels supply. A 2010 study showed they were critical for liver regeneration after injury. Read More
• Cubist Pharmaceuticals Inc., of Lexington, Mass., reported top-line results from its pivotal Phase III study of antibiotic candidate ceftolozane/tazobactam in complicated urinary tract infections, showing that the study met its primary endpoint of statistical noninferiority compared to levofloxacin (10 percent noninferiority margin). Read More
• Mallinckrodt Inc., of St. Louis, said the FDA extended the review of the new drug application (NDA) for Xartemis XR (oxycodone hydrochloride and acetaminophen) extended-release tablets, previously known as MNK-795, for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. Read More
